AstraZeneca seeks a Regulatory Affairs Senior Manager for its Regional Regulatory Centre of Excellence to lead life cycle management operations across assigned markets. The role combines senior regulatory expertise, technical CMC knowledge, and matrix leadership to execute complex regulatory activities while maintaining local marketing company accountability.
Responsibilities
Direct regional life cycle management portfolio aligned with business priorities and service levels
Manage demand, resource allocation, capacity visibility, and governance of transferred activities from marketing companies
Lead complex regulatory activities including dossier customization, submissions, and post-approval change management
Oversee preparation, compilation, and quality review of country-specific regulatory packages
Coordinate timely responses to health authority questions with appropriate stakeholder participation
Requirements
University degree in pharmacy, sciences, chemistry, biology, engineering, or related discipline
Extensive biopharmaceutical regulatory affairs experience with significant life cycle management responsibility
Demonstrated experience managing multiple markets and national regulatory requirements in regional or international settings
Solid knowledge of post-approval regulatory frameworks, national dossier requirements, and CMC change management
Proven experience leading complex regulatory portfolios and multidisciplinary matrix teams
Strong ability to collaborate, influence, and align local, regional, and international stakeholders
Excellent written and verbal communication skills